FDAnews
www.fdanews.com/articles/179084-fda-approves-ide-for-balloon-angioplasty-clinical-study

FDA Approves IDE for Balloon Angioplasty Clinical Study

October 31, 2016

The FDA has granted staged approval for Intact Vascular’s investigational device exemption application to begin its Tack Optimized Balloon Angioplasty II BTK clinical study.

The study will examine the safety and efficacy of the tack endovascular system when used to repair dissections in the arteries below the knee following percutaneous transluminal angioplasty as a treatment for critical limb ischemia.

The study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. — Cynthia Jessup

View today's stories